Medical device maker Coloplast is setting aside an additional $60 million to cover legal settlements and other costs related to its transvaginal mesh product, the company said in a statement. The additional $60 million, on top of $59.3 million that had already set aside for these matters, is not due to an increase of new lawsuits, the company said, but because the “remaining lawsuits are taking longer to resolve than initially expected, hence the incurring higher costs.”
Transvaginal mesh is a type of surgical mesh that is inserted through the vagina to hold up organs, like the bladder or uterus, that have fallen due to age, obesity or difficult childbirth. Several companies sold transvaginal mesh products in the U.S. but were gradually pulling them off the market due to a growing number of adverse event complaints. The devices are prone to eroding into tissue and puncturing organs resulting in chronic pain, disability and incontinence.
Coloplast and Boston Scientific Corp. were the only medical device companies who were still selling transvaginal mesh products in the U.S. in April when the Food and Drug Administration (FDA) ordered all medical device manufacturers to stop selling the mesh in the U.S.
In 2016, the FDA reclassified the mesh as high-risk, which meant manufacturers had to submit premarket approval applications in order to continue selling the products in the U.S. But the FDA found that the companies did not give an adequate assessment of the long-term safety or efficacy of the products compared to other treatments for pelvic organ prolapse that do not use mesh.
“We continue to take market share across all regions and across all business areas, and we continue to invest to drive both short-term growth as well as to build an even stronger and more competitive company for the medium and long term,” said Coloplast CEO Kristian Villumsen, in the statement.